PMID- 29275844
OWN - NLM
STAT- MEDLINE
DCOM- 20191126
LR  - 20191126
IS  - 1557-3117 (Electronic)
IS  - 1053-2498 (Linking)
VI  - 37
IP  - 6
DP  - 2018 Jun
TI  - Left ventricular assist devices versus medical management in ambulatory heart 
      failure patients: An analysis of INTERMACS Profiles 4 and 5 to 7 from the ROADMAP 
      study.
PG  - 706-714
LID - S1053-2498(17)32142-3 [pii]
LID - 10.1016/j.healun.2017.12.003 [doi]
AB  - BACKGROUND: The ROADMAP study showed survival with improved functional status was 
      better with left ventricular assist device (LVAD) therapy compared with optimal 
      medical management (OMM) in ambulatory, non-inotrope-dependent (INTERMACS [IM] 
      Profile 4 to 7) patients. To study more balanced cohorts and better define which 
      patients may benefit from implantation of an LVAD, we re-evaluated the patients 
      enrolled in ROADMAP when stratified by INTERMACS profile (Profile 4 and Profiles 
      5 to 7). METHODS: The primary end-point (survival on original therapy with 
      improvement in 6-minute walk distance >/=75 meters at 1 year), actuarial survival, 
      adverse events (AEs) and health-related quality of life (HRQoL) were evaluated. 
      RESULTS: For INTERMACS Profile 4 (IM4), more LVAD patients met the primary 
      end-point compared with OMM patients (40% vs 15%; odds ratio = 3.9 [1.2 to 12.7], 
      p = 0.024), but there was no statistically significant difference for INTERMACS 
      Profiles IM 5 to 7 (IM5-7). Event-free survival on original therapy at 2 years 
      was greater for LVAD than for OMM patients in both IM4 (67% vs 28%; p < 0.001) 
      and IM5-7 (76% vs 49%; p = 0.025) profile groups. Composite end-points of 
      survival on original therapy with improved HRQoL or depression were better with 
      LVAD than OMM in IM4, but not IM5-7. AEs trended higher in LVAD compared with OMM 
      patients in both profile groups. Rehospitalization rates for LVAD vs OMM were 
      similar between treatment arms in IM4 (82% vs 86%; p = 0.780), but were higher 
      for LVAD in IM5-7 (93% vs 71%; p = 0.016). CONCLUSIONS: LVAD patients in IM4, but 
      not IM5-7, are more likely to meet the primary end-point and have improvements in 
      HRQoL and depression compared with OMM, even with AEs generally being more 
      frequent. LVAD therapy with current technology may be beneficial in select IM4 
      patients, but can be deferred for most IM5-7 patients, who should be followed 
      closely due to the high frequency of treatment failures.
CI  - Copyright (c) 2017 International Society for the Heart and Lung Transplantation. 
      Published by Elsevier Inc. All rights reserved.
FAU - Shah, Keyur B
AU  - Shah KB
AD  - Department of Surgery, Virginia Commonwealth University, Richmond, Virginia, USA. 
      Electronic address: kbs811@gmail.com.
FAU - Starling, Randall C
AU  - Starling RC
AD  - Division of Cardiology, Cleveland Clinic, Cleveland, Ohio, USA.
FAU - Rogers, Joseph G
AU  - Rogers JG
AD  - Division of Cardiology, Duke University, Durham, North Carolina, USA.
FAU - Horstmanshof, Douglas A
AU  - Horstmanshof DA
AD  - Division of Cardiology, INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma, 
      USA.
FAU - Long, James W
AU  - Long JW
AD  - Division of Cardiology, INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma, 
      USA.
FAU - Kasirajan, Vigneshwar
AU  - Kasirajan V
AD  - Department of Surgery, Virginia Commonwealth University, Richmond, Virginia, USA.
FAU - Stehlik, Josef
AU  - Stehlik J
AD  - Division of Cardiology, University of Utah School of Medicine, Salt Lake City, 
      Utah, USA.
FAU - Chuang, Joyce
AU  - Chuang J
AD  - Abbott, Pleasanton, California, USA.
FAU - Farrar, David J
AU  - Farrar DJ
AD  - Abbott, Pleasanton, California, USA.
FAU - Estep, Jerry D
AU  - Estep JD
AD  - Division of Cardiology, Houston Methodist Hospital, Houston, Texas, USA.
CN  - ROADMAP Investigators
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20171207
PL  - United States
TA  - J Heart Lung Transplant
JT  - The Journal of heart and lung transplantation : the official publication of the 
      International Society for Heart Transplantation
JID - 9102703
SB  - IM
CIN - J Heart Lung Transplant. 2018 Jun;37(6):694-695. PMID: 29628136
MH  - Aged
MH  - Female
MH  - Heart Failure/classification/mortality/*therapy
MH  - *Heart-Assist Devices
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Quality of Life
MH  - Survival Rate
MH  - Treatment Outcome
MH  - Walk Test
OTO - NOTNLM
OT  - assisted circulation
OT  - drug therapy
OT  - heart failure
OT  - mechanical circulatory support
OT  - ventricular assist device
EDAT- 2017/12/26 06:00
MHDA- 2019/11/27 06:00
CRDT- 2017/12/26 06:00
PHST- 2017/08/28 00:00 [received]
PHST- 2017/10/17 00:00 [revised]
PHST- 2017/12/05 00:00 [accepted]
PHST- 2017/12/26 06:00 [pubmed]
PHST- 2019/11/27 06:00 [medline]
PHST- 2017/12/26 06:00 [entrez]
AID - S1053-2498(17)32142-3 [pii]
AID - 10.1016/j.healun.2017.12.003 [doi]
PST - ppublish
SO  - J Heart Lung Transplant. 2018 Jun;37(6):706-714. doi: 
      10.1016/j.healun.2017.12.003. Epub 2017 Dec 7.